81_FR_67339 81 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address

81 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 190 (September 30, 2016)

Page Range67149-67153
FR Document2016-23230

The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.

Federal Register, Volume 81 Issue 190 (Friday, September 30, 2016)
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67149-67153]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

[Docket No. FDA-2016-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, we) is amending the 
animal drug regulations to reflect application-related actions for new 
animal drug applications (NADAs) and abbreviated new animal drug 
applications (ANADAs) during July and August 2016. FDA is also 
informing the public of the availability of summaries of the basis of 
approval and of environmental review documents, where applicable. The 
animal drug regulations are also being amended to reflect a change of a 
sponsor's address.

[[Page 67150]]


DATES: This rule is effective September 30, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during July and August 2016, as listed in 
table 1. In addition, FDA is informing the public of the availability, 
where applicable, of documentation of environmental review required 
under the National Environmental Policy Act (NEPA) and, for actions 
requiring review of safety or effectiveness data, summaries of the 
basis of approval (FOI Summaries) under the Freedom of Information Act 
(FOIA). These public documents may be seen in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday 
through Friday. Persons with access to the Internet may obtain these 
documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be 
accessed in FDA's publication, Approved Animal Drug Products Online 
(Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                                Table 1--Original and Supplemental NADAs and ANADAs Approved During July and August 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Effect of the
         Approval date            File No.        Sponsor          Product name             Species          action/indications      Public documents
                                                                                                                   for use
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 24, 2016..................    141-458  Merial, Inc., 3239  EQUIOXX             Horses.................  Original approval   FOI Summary.
                                             Satellite Blvd.,    (firocoxib)                                  for the control
                                             bldg. 500,          Tablets.                                     of pain and
                                             Duluth, GA 30096-                                                inflammation
                                             4640.                                                            associated with
                                                                                                              osteoarthritis in
                                                                                                              horses.
July 20, 2016..................    141-459  Intervet, Inc., 2   BRAVECTO            Dogs, cats.............  Original approval   FOI Summary.
                                             Giralda Farms,      (fluralaner                                  for killing adult
                                             Madison, NJ 07940.  topical solution)                            fleas, for the
                                                                 for Dogs.                                    treatment and
                                                                BRAVECTO                                      prevention of
                                                                 (fluralaner                                  flea
                                                                 topical solution)                            infestations, and
                                                                 for Cats.                                    for the treatment
                                                                                                              and control of
                                                                                                              tick infestations
                                                                                                              in dogs and cats.
August 12, 2016................    141-461  Aratana             NOCITA              Dogs...................  Original approval   FOI Summary.
                                             Therapeutics,       (bupivacaine                                 to provide local
                                             Inc., 11400         liposome                                     postoperative
                                             Tomahawk Creek      injectable                                   analgesia for
                                             Pkwy., Leawood,     suspension).                                 cranial cruciate
                                             KS 66211.                                                        ligament surgery
                                                                                                              in dogs.
July 1, 2016...................    200-501  Cross Vetpharm      Praziquantel        Dogs...................  Original approval   FOI Summary.
                                             Group Ltd.          (praziquantel)                               of a generic copy
                                             Broomhill Rd.,      Injection.                                   of NADA 111-607.
                                             Tallaght, Dublin
                                             24, Ireland.
August 5, 2016.................    200-508  Cross Vetpharm      BILOVET (tylosin)   Cattle, swine..........  Original approval   FOI Summary.
                                             Group Ltd.          Injection.                                   of a generic copy
                                             Broomhill Rd.,                                                   of NADA 012-965.
                                             Tallaght, Dublin
                                             24, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsor's Address

    Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., Madison, 
WI 53719 has informed FDA that it has changed its address to P.O. Box 
259158, Madison, WI 53725. Accordingly, the regulations at 21 CFR 
510.600(c) will be amended to reflect this sponsor's change of address.

III. Technical Amendments

    FDA has noticed that drug labeler codes (DLCs) in several sections 
of part 558 (21 CFR part 558) do not accurately reflect the sponsorship 
of a new animal drug application. At this time, we are amending part 
558 to remove these DLCs. Also, FDA is amending the regulations to 
revise a human food safety warning for tulathromycin injectable 
solution in 21 CFR 522.2630 and to correct a cross-reference for 
combination medicated feeds in Sec.  558.128 (21 CFR 558.128). These 
actions are being taken to improve the accuracy of the regulations.
    The restrictions for veterinary feed directive (VFD) drugs in part 
558 are being revised to reflect a uniform text. In addition, we are 
revising Sec.  558.59 to reflect a current format. These actions are 
being taken to improve the clarity of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.


[[Page 67151]]


    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 
520, 522, 524, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


Sec.  510.600  [Amended]

0
2. Revise Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1):
0
i. In the entries for ``Cronus Pharma LLC'', ``HQ Specialty Pharma 
Corp.'', ``OXIS International, Inc.'', ``Pharmgate LLC ``, ``Putney, 
Inc.'', ``SmartVet USA, Inc.'', and ``Wildlife Laboratories, Inc.'', 
remove ``Suite'' and in its place add ``suite'';
0
ii. In the entry for ``Merial, Inc.'', remove ``Bldg.'' and in its 
place add ``bldg.'';
0
iii. In the entry for ``Nexcyon Pharmaceuticals, Inc.'', remove ``644 
West Washington Ave., Madison, WI 53719'' and in its place add ``P.O. 
Box 259158, Madison, WI 53725'';
0
b. In the table in paragraph (c)(2):
0
i. In the entries for ``024991'', ``026637'', ``042791'', ``053923'', 
``069043'', ``069254'', and ``086001'', remove ``Suite'' and in its 
place add ``suite'';
0
ii. In the entry for ``050604'', remove ``Bldg.'' and in its place add 
``bldg.''; and
0
iii. In the entry for ``050929'', remove ``644 West Washington Ave., 
Madison, WI 53719'' and in its place add ``P.O. Box 259158, Madison, WI 
53725''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority:  21 U.S.C. 360b

0
4. In Sec.  520.928, revise paragraph (c) to read as follows:


Sec.  520.928  Firocoxib tablets.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 mg/kg (2.27 mg/lb) 
body weight. Administer once daily for osteoarthritis. Administer 
approximately 2 hours before soft tissue or orthopedic surgery.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis; and for the control of postoperative 
pain and inflammation associated with soft-tissue and orthopedic 
surgery.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer one 57-mg tablet to horses 
weighing 800 to 1,300 lb once daily for up to 14 days.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.


Sec.  520.2345c  [Amended]

0
5. In Sec.  520.2345c, remove paragraph (d)(1)(iii).

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for part 522 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
7. Add Sec.  522.224 to read as follows:


Sec.  522.224  Bupivacaine.

    (a) Specifications. Each milliliter (mL) of liposomal suspension 
contains 13.3 milligrams (mg) bupivacaine.
    (b) Sponsor. See No. 086026 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 5.3 mg/kg 
(0.4 mL/kg) by infiltration injection into the tissue layers at the 
time of incisional closure.
    (2) Indications for use. For single-dose infiltration into the 
surgical site to provide local postoperative analgesia for cranial 
cruciate ligament surgery in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
0
8. In Sec.  522.1870, revise paragraphs (a), (c)(1)(i) and (iii), and 
(c)(2)(i) and (iii) to read as follows:


Sec.  522.1870  Praziquantel.

    (a) Specifications. Each milliliter (mL) of solution contains 56.8 
milligrams of praziquantel.
* * * * *
    (c) * * *
    (1) * * *
    (i) Amount. Administer by subcutaneous or intramuscular injection 
for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 
0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight 
to a maximum of 3 mL.
* * * * *
    (iii) Limitations. Federal law restricts the drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. Administer by subcutaneous or intramuscular injection 
for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and 
over, 0.6 mL maximum.
* * * * *
    (iii) Limitations. Federal law restricts the drug to use by or on 
the order of a licensed veterinarian.
0
9. In Sec.  522.2630, revise paragraph (d)(1)(iii)(A) to read as 
follows:


Sec.  522.2630  Tulathromycin.

* * * * *
    (d) * * *
    (1) * * *
    (iii) * * *
    (A) Cattle intended for human consumption must not be slaughtered 
within 18 days from the last treatment. This drug is not approved for 
use in female dairy cattle 20 months of age or older, including dry 
dairy cows. Use in these cattle may cause drug residues in milk and/or 
in calves born to these cows. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
* * * * *
0
10. Revise Sec.  522.2640 to read as follows:


Sec.  522.2640  Tylosin.

    (a) Specifications. Each milliliter (mL) of solution contains 50 or 
200 milligrams (mg) of tylosin activity (as tylosin base).
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:
    (1) No. 000986 for use of 50- or 200-mg/mL solutions as in 
paragraph (e) of this section.
    (2) Nos. 000010 and 061623 for use of a 200-mg/mL solution as in 
paragraphs (e)(1) and (2) of this section.
    (c) Related tolerances. See Sec.  556.740 of this chapter.
    (d) Special considerations. Labeling must bear the warning 
statements: ``Do not administer to horses or other equines. Injection 
of tylosin in equines has been fatal.''
    (e) Conditions of use--(1) Beef cattle and nonlactating dairy 
cattle--(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by 
intramuscular injection once daily for not more than 5 consecutive 
days. Continue treatment 24 hours after symptoms disappear.
    (ii) Indications for use. Treatment of bovine respiratory complex 
(shipping fever, pneumonia) usually associated with Pasteurella 
multocida and Arcanobacterium pyogenes; foot rot (necrotic 
pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum 
and metritis caused by A. pyogenes.

[[Page 67152]]

    (iii) Limitations. Do not inject more than 10 mL per site. Use a 
50-mg/mL solution for calves weighing less than 200 pounds. Cattle 
intended for human consumption must not be slaughtered within 21 days 
of the last use of this drug product. This drug product is not approved 
for use in female dairy cattle 20 months of age or older, including dry 
dairy cows. Use in these cattle may cause drug residues in milk and/or 
in calves born to these cows. This product is not approved for use in 
calves intended to be processed for veal. A withdrawal period has not 
been established in preruminating calves.
    (2) Swine--(i) Amount. Administer 4 mg/lb of body weight by 
intramuscular injection twice daily for not more than 3 consecutive 
days. Continue treatment 24 hours after symptoms disappear. If tylosin 
medicated drinking water is used as a followup treatment for swine 
dysentery, the animal should thereafter receive feed containing 40 to 
100 grams of tylosin per ton for 2 weeks to assure depletion of tissue 
residues.
    (ii) Indications for use. Treatment of swine arthritis caused by 
Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; 
swine erysipelas caused by Erysipelothrix rhusiopathiae; swine 
dysentery associated with Treponema hyodysenteriae when followed by 
appropriate medication in the drinking water and/or feed.
    (iii) Limitations. Do not inject more than 5 mL per site. Adverse 
reactions, including shock and death may result from overdosage in baby 
pigs. It is recommended that tylosin 50-mg/mL injection be used in pigs 
weighing less than 25 lbs. Swine intended for human consumption must 
not be slaughtered within 14 days of the last use of this drug product.
    (3) Dogs and cats--(i) Amount. Administer 3 to 5 mg/lb of body 
weight by intramuscular injection at 12- to 24-hour intervals.
    (ii) Indications for use--(A) Dogs. Treatment of upper respiratory 
infections such as bronchitis, tracheobronchitis, tracheitis, 
laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., 
hemolytic Streptococci spp., and Pasteurella multocida.
    (B) Cats. Treatment of upper respiratory infections when caused by 
Staphylococci spp. and hemolytic Streptococci spp. and for feline 
pneumonitis when caused by tylosin-susceptible organisms.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for part 524 continues to read as follows:

    Authority:  21 U.S.C. 360b.

0
12. Add Sec.  524.998 to read as follows:


Sec.  524.998  Fluralaner.

    (a) Specifications. Each milliliter of solution contains 280 
milligrams (mg) fluralaner.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer topically 
as a single dose every 12 weeks according to the label dosage schedule 
to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be 
administered every 8 weeks in case of potential exposure to Amblyomma 
americanum ticks.
    (ii) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis) and the 
treatment and control of tick infestations (Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and 
Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and 
puppies 6 months of age and older, and weighing 4.4 lb or greater; for 
the treatment and control of A. americanum (lone star tick) 
infestations for 8 weeks in dogs and puppies 6 months of age and older, 
and weighing 4.4 lb or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
13. The authority citation for part 529 continues to read as follows:

    Authority:  21 U.S.C. 360b.


Sec.  529.400  [Amended]

0
14. In Sec.  529.400, in paragraph (a), remove footnote 1.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
15. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.


Sec.  558.58  [Amended]

0
16. In Sec.  558.58, in paragraph (e)(6), remove ``3.6'' and in its 
place add ``36.6''.
0
17. Revise Sec.  558.59 to read as follows:


Sec.  558.59  Apramycin.

    (a) Specifications. Each pound of Type A article contains 75 grams 
apramycin (as apramycin sulfate).
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Related tolerances. See Sec.  556.52 of this chapter.
    (e) Conditions of use in swine--(1) Amount. Feed at 150 grams 
apramycin per ton of Type C medicated feed as the sole ration for 14 
consecutive days.
    (2) Indications for use. For control of porcine colibacillosis 
(weanling pig scours) caused by susceptible strains of Escherichia 
coli.
    (3) Limitations. Withdraw 28 days before slaughter.


Sec.  558.68  [Amended]

0
18. In Sec.  558.68, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (c); and in paragraphs (e)(1)(i) and (e)(2)(i), remove 
``000986'' and in its place add ``058198''.


Sec.  558.128  [Amended]

0
19. In Sec.  558.128, in paragraph (e)(7)(xi), remove ``Sec.  558.600'' 
and in its place add ''Sec.  558.612''.


Sec.  558.195  [Amended]

0
20. In Sec.  558.195, in paragraph (e)(1)(vi), remove ``000009'' and in 
its place add ``054771''; and in paragraphs (e)(2)(iii) and (v), remove 
``000986'' wherever it appears and in its place add ``058198''.


Sec.  558.261  [Amended]

0
21. In Sec.  558.261, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (c).


Sec.  558.295  [Amended]

0
22. In Sec.  558.295, remove and reserve paragraph (b).
0
23. In Sec.  558.325, revise paragraph (d)(3) to read as follows:


Sec.  558.325  Lincomycin.

* * * * *
    (d) * * *
    (3) Labeling of Type A medicated articles and single-ingredient 
Type B and Type C medicated feeds containing lincomycin intended for 
use in swine shall bear the following caution statement: ``The effects 
of lincomycin on swine reproductive performance, pregnancy, and 
lactation have not been determined. Not for use in swine intended for 
breeding when lincomycin is fed at 20 grams per ton of complete feed.''
* * * * *


Sec.  558.342  [Amended]

0
24. In Sec.  558.342, in paragraphs (e)(1)(iv),(ix), (x), and (xi), 
remove

[[Page 67153]]

``000986'' wherever it appears and in its place add ``058198''.


Sec.  558.366  [Amended]

0
25. In Sec.  558.366, in paragraph (d), in the entry for ``113.5 
(0.0125 pct)'', remove ``000986'' and in its place add ``058198''.


Sec.  558.618  [Amended]

0
26. In Sec.  558.618, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (c).
0
27. In Sec.  558.633, revise paragraph (d)(1) to read as follows:


Sec.  558.633  Tylvalocin.

* * * * *
    (d) * * *
    (1) Federal law restricts medicated feed containing this veterinary 
feed directive (VFD) drug to use by or on the order of a licensed 
veterinarian. See Sec.  558.6 for additional requirements.
* * * * *

    Dated: September 21, 2016.
Tracey Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-23230 Filed 9-29-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                                   Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations                                             67149

                                                  a petition is classified, as identified by                 (i) Petitions for duty suspensions and               (b) Exceptions. (1) In calculating the
                                                  documentation supplied to the                           reductions that the Commission has                    estimated revenue loss required under
                                                  Commission and any supporting                           determined do not contain the                         the Act, the Commission may base its
                                                  information obtained by the                             information required under section                    estimates in whole or in part on the
                                                  Commission.                                             3(b)(2) of the Act.                                   estimated values of imports submitted
                                                     (2) A determination of whether or not                   (ii) Petitions for duty suspensions and            by petitioners in their petitions.
                                                  domestic production of the article that                 reductions with respect to which the                    (2) The Commission may disclose
                                                  is the subject of the petition exists,                  Commission has determined the                         some or all of the confidential business
                                                  taking into account the report of the                   petitioner is not a likely beneficiary.               information provided to the
                                                  Secretary of Commerce under section                        (6) A list of petitions for duty                   Commission in petitions and public
                                                  3(c)(1) of the Act, and, if such                        suspensions and reductions that the                   comments to the U.S. Department of
                                                  production exists, whether or not a                     Commission does not recommend for                     Commerce for use in preparing its report
                                                  domestic producer of the article objects                inclusion in a miscellaneous tariff bill,             to the Commission and the Committees,
                                                  to the duty suspension or reduction.                    other than petitions specified in section             and to the U.S. Department of
                                                     (3) Any technical changes to the                     3(b)(3)(C)(ii)(V) of the Act.                         Agriculture and CBP for use in
                                                  description of the article that is the                     (c) The Commission will forward to                 providing information for Commerce’s
                                                  subject of the petition for the duty                    the Committees any additional                         report.
                                                  suspension or reduction that are                        information submitted to the                          § 220.14   Application of other Commission
                                                  necessary for purposes of administration                Commission by the Secretary of                        rules.
                                                  when the article is presented for                       Commerce after the Commission
                                                                                                                                                                  Commission rules applicable to the
                                                  importation, taking into account the                    transmits its preliminary report.
                                                                                                                                                                initiation and conduct of investigations,
                                                  report of the Secretary of Commerce
                                                                                                          § 220.12    Commission final report.                  including rules set out in subpart B of
                                                  under section 3(c)(2) of the Act.
                                                     (4) An estimate of the amount of loss                   (a) The Commission will submit its                 part 201 of this chapter (except § 201.9
                                                  in revenue to the United States that                    final report on each petition for a duty              (methods employed in obtaining
                                                  would no longer be collected if the duty                suspension or reduction specified in the              information), § 201.14(a) (computation
                                                                                                          preliminary report to the Committees                  of time), and § 201.15 (attorneys or
                                                  suspension or reduction takes effect.
                                                     (5) A determination of whether or not                not later than 60 days after the                      agents)), shall not apply to Commission
                                                  the duty suspension or reduction is                     Commission submits its preliminary                    proceedings under this part.
                                                  available to any person that imports the                report. The final report will contain the               By order of the Commission.
                                                  article that is the subject of the duty                 following information—                                  Issued: September 21, 2016.
                                                  suspension or reduction.                                   (1) The information required to be                 Lisa R. Barton,
                                                     (6) The likely beneficiaries of each                 included in a preliminary report under                Secretary to the Commission.
                                                  duty suspension or reduction, including                 section 3(b)(3)(C)(i)–(ii) of the Act and             [FR Doc. 2016–23229 Filed 9–29–16; 8:45 am]
                                                  whether the petitioner is a likely                      updated as appropriate after considering              BILLING CODE 7020–02–P
                                                  beneficiary.                                            any information submitted by the
                                                     (b) The preliminary report will also                 Committees under section 3(b)(3)(D) of
                                                  include the following information:                      the Act.
                                                     (1) A list of petitions for duty                                                                           DEPARTMENT OF HEALTH AND
                                                                                                             (2) A determination of the                         HUMAN SERVICES
                                                  suspensions and reductions that meet                    Commission whether—
                                                  the requirements of the Act without                        (i) The duty suspension or reduction               Food and Drug Administration
                                                  modifications.                                          can likely be administered by U.S.
                                                     (2) A list of petitions for duty                     Customs and Border Protection;                        21 CFR Parts 510, 520, 522, 524, 529,
                                                  suspensions and reductions for which                       (ii) The estimated loss in revenue to              and 558
                                                  the Commission recommends technical                     the United States from the duty
                                                  corrections (i.e., corrections to the                   suspension or reduction does not                      [Docket No. FDA–2016–N–0002]
                                                  article description that do not otherwise               exceed $500,000 in a calendar year
                                                  substantially alter the scope or HTS                                                                          New Animal Drugs; Approval of New
                                                                                                          during which the duty suspension or                   Animal Drug Applications; Change of
                                                  classification of the articles covered by               reduction would be in effect; and
                                                  the petition) in order to meet the                                                                            Sponsor’s Address
                                                                                                             (iii) The duty suspension or reduction
                                                  requirements of the Act, with the                       is available to any person importing the              AGENCY:    Food and Drug Administration,
                                                  correction specified.                                   articles that is the subject of the duty              HHS.
                                                     (3) A list of petitions for duty                     suspension or reduction.                                    Final rule; technical
                                                                                                                                                                ACTION:
                                                  suspensions and reductions for which                       (b) [Reserved]                                     amendment.
                                                  the Commission recommends
                                                  modifications to the amount of the duty                 § 220.13 Confidential business                        SUMMARY:   The Food and Drug
                                                  suspension or reduction that is the                     information.                                          Administration (FDA, we) is amending
                                                  subject of the petition to comply with                    (a) In general. The Commission will                 the animal drug regulations to reflect
                                                  the requirements of the Act, with the                   not release information which the                     application-related actions for new
                                                  modification specified.                                 Commission considers to be                            animal drug applications (NADAs) and
                                                     (4) A list of petitions for duty                     confidential business information                     abbreviated new animal drug
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  suspensions and reductions for which                    within the meaning of § 201.6(a) of this              applications (ANADAs) during July and
                                                  the Commission recommends                               chapter unless the party submitting the               August 2016. FDA is also informing the
                                                  modifications to the scope of the articles              confidential business information had                 public of the availability of summaries
                                                  that are the subject of the petitions in                notice, at the time of submission, that               of the basis of approval and of
                                                  order to address objections by domestic                 such information would be released by                 environmental review documents,
                                                  producers to such petitions, with the                   the Commission, or such party                         where applicable. The animal drug
                                                  modifications specified.                                subsequently consents to the release of               regulations are also being amended to
                                                     (5) A list of the following:                         the information.                                      reflect a change of a sponsor’s address.


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                                                  67150              Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations

                                                  DATES: This rule is effective September                   and August 2016, as listed in table 1. In                  a.m. and 4 p.m., Monday through
                                                  30, 2016.                                                 addition, FDA is informing the public of                   Friday. Persons with access to the
                                                  FOR FURTHER INFORMATION CONTACT:
                                                                                                            the availability, where applicable, of                     Internet may obtain these documents at
                                                  George K. Haibel, Center for Veterinary                   documentation of environmental review                      the CVM FOIA Electronic Reading
                                                  Medicine (HFV–6), Food and Drug                           required under the National                                Room: http://www.fda.gov/AboutFDA/
                                                  Administration, 7519 Standish Pl.,                        Environmental Policy Act (NEPA) and,                       CentersOffices/OfficeofFoods/CVM/
                                                                                                            for actions requiring review of safety or                  CVMFOIAElectronicReadingRoom/
                                                  Rockville, MD 20855, 240–402–5689,
                                                                                                            effectiveness data, summaries of the                       default.htm. Marketing exclusivity and
                                                  george.haibel@fda.hhs.gov.
                                                                                                            basis of approval (FOI Summaries)                          patent information may be accessed in
                                                  SUPPLEMENTARY INFORMATION:                                under the Freedom of Information Act
                                                                                                                                                                       FDA’s publication, Approved Animal
                                                  I. Approval Actions                                       (FOIA). These public documents may be
                                                                                                                                                                       Drug Products Online (Green Book) at:
                                                                                                            seen in the Division of Dockets
                                                                                                                                                                       http://www.fda.gov/AnimalVeterinary/
                                                    FDA is amending the animal drug                         Management (HFA–305), Food and Drug
                                                  regulations to reflect approval actions                   Administration, 5630 Fishers Lane, Rm.                     Products/ApprovedAnimalDrug
                                                  for NADAs and ANADAs during July                          1061, Rockville, MD 20852, between 9                       Products/default.htm.

                                                           TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY AND AUGUST 2016
                                                                                                                                                                                Effect of the action/        Public
                                                         Approval date                File No.           Sponsor                 Product name               Species             indications for use        documents

                                                  July 24, 2016 ..................    141–458    Merial, Inc., 3239           EQUIOXX (firocoxib)      Horses ..............    Original approval for    FOI Summary.
                                                                                                  Satellite Blvd.,             Tablets.                                           the control of pain
                                                                                                  bldg. 500, Duluth,                                                              and inflammation
                                                                                                  GA 30096–4640.                                                                  associated with
                                                                                                                                                                                  osteoarthritis in
                                                                                                                                                                                  horses.
                                                  July 20, 2016 ..................    141–459    Intervet, Inc., 2            BRAVECTO                 Dogs, cats ........      Original approval for    FOI Summary.
                                                                                                    Giralda Farms,             (fluralaner topical                                killing adult fleas,
                                                                                                    Madison, NJ                solution) for Dogs.                                for the treatment
                                                                                                    07940.                    BRAVECTO                                            and prevention of
                                                                                                                               (fluralaner topical                                flea infestations,
                                                                                                                               solution) for Cats.                                and for the treat-
                                                                                                                                                                                  ment and control
                                                                                                                                                                                  of tick infestations
                                                                                                                                                                                  in dogs and cats.
                                                  August 12, 2016 .............       141–461    Aratana Thera-               NOCITA                   Dogs .................   Original approval to     FOI Summary.
                                                                                                   peutics, Inc.,              (bupivacaine                                       provide local post-
                                                                                                   11400 Tomahawk              liposome                                           operative analge-
                                                                                                   Creek Pkwy.,                injectable suspen-                                 sia for cranial
                                                                                                   Leawood, KS                 sion).                                             cruciate ligament
                                                                                                   66211.                                                                         surgery in dogs.
                                                  July 1, 2016 ....................   200–501    Cross Vetpharm               Praziquantel             Dogs .................   Original approval of     FOI Summary.
                                                                                                   Group Ltd.                   (praziquantel) In-                                a generic copy of
                                                                                                   Broomhill Rd.,               jection.                                          NADA 111–607.
                                                                                                   Tallaght, Dublin
                                                                                                   24, Ireland.
                                                  August 5, 2016 ...............      200–508    Cross Vetpharm               BILOVET (tylosin)        Cattle, swine .....      Original approval of     FOI Summary.
                                                                                                   Group Ltd.                   Injection.                                        a generic copy of
                                                                                                   Broomhill Rd.,                                                                 NADA 012–965.
                                                                                                   Tallaght, Dublin
                                                                                                   24, Ireland.



                                                  II. Change of Sponsor’s Address                           DLCs. Also, FDA is amending the                            it is a rule of ‘‘particular applicability.’’
                                                                                                            regulations to revise a human food                         Therefore, it is not subject to the
                                                    Nexcyon Pharmaceuticals, Inc., 644                      safety warning for tulathromycin                           congressional review requirements in 5
                                                  West Washington Ave., Madison, WI                         injectable solution in 21 CFR 522.2630                     U.S.C. 801–808.
                                                  53719 has informed FDA that it has                        and to correct a cross-reference for
                                                  changed its address to P.O. Box 259158,                                                                              List of Subjects
                                                                                                            combination medicated feeds in
                                                  Madison, WI 53725. Accordingly, the                       § 558.128 (21 CFR 558.128). These                          21 CFR Part 510
                                                  regulations at 21 CFR 510.600(c) will be                  actions are being taken to improve the
                                                  amended to reflect this sponsor’s change                  accuracy of the regulations.                                 Administrative practice and
                                                  of address.                                                 The restrictions for veterinary feed                     procedure, Animal drugs, Labeling,
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                                                                                                            directive (VFD) drugs in part 558 are                      Reporting and recordkeeping
                                                  III. Technical Amendments
                                                                                                            being revised to reflect a uniform text.                   requirements.
                                                    FDA has noticed that drug labeler                       In addition, we are revising § 558.59 to                   21 CFR Parts 520, 522, 524, and 529
                                                  codes (DLCs) in several sections of part                  reflect a current format. These actions
                                                  558 (21 CFR part 558) do not accurately                   are being taken to improve the clarity of                     Animal drugs.
                                                  reflect the sponsorship of a new animal                   the regulations.                                           21 CFR Part 558
                                                  drug application. At this time, we are                      This rule does not meet the definition
                                                  amending part 558 to remove these                         of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because                     Animal drugs, Animal feeds.


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                                                                   Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations                                        67151

                                                    Therefore, under the Federal Food,                       (iii) Limitations. Federal law restricts              (2) * * *
                                                  Drug, and Cosmetic Act and under                        this drug to use by or on the order of                   (i) Amount. Administer by
                                                  authority delegated to the Commissioner                 a licensed veterinarian.                              subcutaneous or intramuscular injection
                                                  of Food and Drugs and redelegated to                       (2) Horses—(i) Amount. Administer                  for cats and kittens under 5 lb, 0.2 mL;
                                                  the Center for Veterinary Medicine, 21                  one 57-mg tablet to horses weighing 800               5 to 10 lb, 0.4 mL; 11 lb and over, 0.6
                                                  CFR parts 510, 520, 522, 524, 529, and                  to 1,300 lb once daily for up to 14 days.             mL maximum.
                                                  558 are amended as follows:                                (ii) Indications for use. For the control          *       *    *     *     *
                                                                                                          of pain and inflammation associated                      (iii) Limitations. Federal law restricts
                                                  PART 510—NEW ANIMAL DRUGS                               with osteoarthritis.                                  the drug to use by or on the order of a
                                                                                                             (iii) Limitations. Do not use in horses            licensed veterinarian.
                                                  ■ 1. The authority citation for part 510                intended for human consumption.                       ■ 9. In § 522.2630, revise paragraph
                                                  continues to read as follows:                           Federal law restricts this drug to use by             (d)(1)(iii)(A) to read as follows:
                                                    Authority: 21 U.S.C. 321, 331, 351, 352,              or on the order of a licensed
                                                  353, 360b, 371, 379e.                                   veterinarian.                                         § 522.2630   Tulathromycin.
                                                  § 510.600    [Amended]                                                                                        *      *    *    *     *
                                                                                                          § 520.2345c       [Amended]                             (d) * * *
                                                  ■  2. Revise § 510.600 as follows:                      ■ 5. In § 520.2345c, remove paragraph                   (1) * * *
                                                  ■  a. In the table in paragraph (c)(1):                 (d)(1)(iii).                                            (iii) * * *
                                                  ■  i. In the entries for ‘‘Cronus Pharma                                                                        (A) Cattle intended for human
                                                  LLC’’, ‘‘HQ Specialty Pharma Corp.’’,                   PART 522—IMPLANTATION OR                              consumption must not be slaughtered
                                                  ‘‘OXIS International, Inc.’’, ‘‘Pharmgate               INJECTABLE DOSAGE FORM NEW                            within 18 days from the last treatment.
                                                  LLC ‘‘, ‘‘Putney, Inc.’’, ‘‘SmartVet USA,               ANIMAL DRUGS                                          This drug is not approved for use in
                                                  Inc.’’, and ‘‘Wildlife Laboratories, Inc.’’,                                                                  female dairy cattle 20 months of age or
                                                  remove ‘‘Suite’’ and in its place add                   ■ 6. The authority citation for part 522
                                                                                                                                                                older, including dry dairy cows. Use in
                                                  ‘‘suite’’;                                              continues to read as follows:
                                                                                                                                                                these cattle may cause drug residues in
                                                  ■ ii. In the entry for ‘‘Merial, Inc.’’,                    Authority: 21 U.S.C. 360b.                        milk and/or in calves born to these
                                                  remove ‘‘Bldg.’’ and in its place add
                                                                                                          ■   7. Add § 522.224 to read as follows:              cows. Federal law restricts this drug to
                                                  ‘‘bldg.’’;
                                                  ■ iii. In the entry for ‘‘Nexcyon
                                                                                                                                                                use by or on the order of a licensed
                                                                                                          § 522.224    Bupivacaine.
                                                  Pharmaceuticals, Inc.’’, remove ‘‘644                                                                         veterinarian.
                                                                                                             (a) Specifications. Each milliliter (mL)
                                                  West Washington Ave., Madison, WI                                                                             *      *    *    *     *
                                                                                                          of liposomal suspension contains 13.3                 ■ 10. Revise § 522.2640 to read as
                                                  53719’’ and in its place add ‘‘P.O. Box                 milligrams (mg) bupivacaine.
                                                  259158, Madison, WI 53725’’;                                                                                  follows:
                                                                                                             (b) Sponsor. See No. 086026 in
                                                  ■ b. In the table in paragraph (c)(2):
                                                                                                          § 510.600(c) of this chapter.                         § 522.2640   Tylosin.
                                                  ■ i. In the entries for ‘‘024991’’,
                                                                                                             (c) Conditions of use in dogs—(1)                    (a) Specifications. Each milliliter (mL)
                                                  ‘‘026637’’, ‘‘042791’’, ‘‘053923’’,                     Amount. Administer 5.3 mg/kg (0.4 mL/
                                                  ‘‘069043’’, ‘‘069254’’, and ‘‘086001’’,                                                                       of solution contains 50 or 200
                                                                                                          kg) by infiltration injection into the                milligrams (mg) of tylosin activity (as
                                                  remove ‘‘Suite’’ and in its place add
                                                                                                          tissue layers at the time of incisional               tylosin base).
                                                  ‘‘suite’’;
                                                                                                          closure.                                                (b) Sponsors. See sponsors in
                                                  ■ ii. In the entry for ‘‘050604’’, remove
                                                                                                             (2) Indications for use. For single-dose           § 510.600(c) of this chapter as follows:
                                                  ‘‘Bldg.’’ and in its place add ‘‘bldg.’’;
                                                                                                          infiltration into the surgical site to                   (1) No. 000986 for use of 50- or 200-
                                                  and
                                                  ■ iii. In the entry for ‘‘050929’’, remove
                                                                                                          provide local postoperative analgesia for             mg/mL solutions as in paragraph (e) of
                                                  ‘‘644 West Washington Ave., Madison,                    cranial cruciate ligament surgery in                  this section.
                                                  WI 53719’’ and in its place add ‘‘P.O.                  dogs.                                                    (2) Nos. 000010 and 061623 for use of
                                                                                                             (3) Limitations. Federal law restricts             a 200-mg/mL solution as in paragraphs
                                                  Box 259158, Madison, WI 53725’’.
                                                                                                          this drug to use by or on the order of                (e)(1) and (2) of this section.
                                                  PART 520—ORAL DOSAGE FORM                               a licensed veterinarian.                                 (c) Related tolerances. See § 556.740
                                                  NEW ANIMAL DRUGS                                        ■ 8. In § 522.1870, revise paragraphs (a),            of this chapter.
                                                                                                          (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to          (d) Special considerations. Labeling
                                                  ■ 3. The authority citation for part 520                read as follows:                                      must bear the warning statements: ‘‘Do
                                                  continues to read as follows:                                                                                 not administer to horses or other
                                                                                                          § 522.1870    Praziquantel.
                                                      Authority: 21 U.S.C. 360b                                                                                 equines. Injection of tylosin in equines
                                                                                                             (a) Specifications. Each milliliter (mL)           has been fatal.’’
                                                  ■ 4. In § 520.928, revise paragraph (c) to              of solution contains 56.8 milligrams of
                                                  read as follows:                                                                                                 (e) Conditions of use—(1) Beef cattle
                                                                                                          praziquantel.                                         and nonlactating dairy cattle—(i)
                                                  § 520.928    Firocoxib tablets.                         *       *    *     *     *                            Amount. Administer 8 mg per pound
                                                  *      *    *     *     *                                  (c) * * *                                          (mg/lb) of body weight by intramuscular
                                                    (c) Conditions of use—(1) Dogs—(i)                       (1) * * *                                          injection once daily for not more than
                                                  Amount. 5 mg/kg (2.27 mg/lb) body                          (i) Amount. Administer by                          5 consecutive days. Continue treatment
                                                  weight. Administer once daily for                       subcutaneous or intramuscular injection               24 hours after symptoms disappear.
                                                  osteoarthritis. Administer                              for dogs and puppies 5 pounds (lb) and                   (ii) Indications for use. Treatment of
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                                                  approximately 2 hours before soft tissue                under, 0.3 mL; for 6 to 10 lb, 0.5 mL;                bovine respiratory complex (shipping
                                                  or orthopedic surgery.                                  for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2           fever, pneumonia) usually associated
                                                    (ii) Indications for use. For the control             mL/5 lb body weight to a maximum of                   with Pasteurella multocida and
                                                  of pain and inflammation associated                     3 mL.                                                 Arcanobacterium pyogenes; foot rot
                                                  with osteoarthritis; and for the control                *       *    *     *     *                            (necrotic pododermatitis) and calf
                                                  of postoperative pain and inflammation                     (iii) Limitations. Federal law restricts           diphtheria caused by Fusobacterium
                                                  associated with soft-tissue and                         the drug to use by or on the order of a               necrophorum and metritis caused by A.
                                                  orthopedic surgery.                                     licensed veterinarian.                                pyogenes.


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                                                  67152            Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations

                                                     (iii) Limitations. Do not inject more                PART 524—OPHTHALMIC AND                               § 558.59    Apramycin.
                                                  than 10 mL per site. Use a 50-mg/mL                     TOPICAL DOSAGE FORM NEW                                 (a) Specifications. Each pound of
                                                  solution for calves weighing less than                  ANIMAL DRUGS                                          Type A article contains 75 grams
                                                  200 pounds. Cattle intended for human                                                                         apramycin (as apramycin sulfate).
                                                  consumption must not be slaughtered                     ■ 11. The authority citation for part 524               (b) Sponsor. See No. 058198 in
                                                  within 21 days of the last use of this                  continues to read as follows:                         § 510.600(c) of this chapter.
                                                  drug product. This drug product is not                                                                          (c) [Reserved]
                                                                                                              Authority: 21 U.S.C. 360b.
                                                  approved for use in female dairy cattle                                                                         (d) Related tolerances. See § 556.52 of
                                                  20 months of age or older, including dry                ■   12. Add § 524.998 to read as follows:             this chapter.
                                                  dairy cows. Use in these cattle may                                                                             (e) Conditions of use in swine—(1)
                                                                                                          § 524.998    Fluralaner.
                                                  cause drug residues in milk and/or in                                                                         Amount. Feed at 150 grams apramycin
                                                  calves born to these cows. This product                    (a) Specifications. Each milliliter of             per ton of Type C medicated feed as the
                                                  is not approved for use in calves                       solution contains 280 milligrams (mg)                 sole ration for 14 consecutive days.
                                                  intended to be processed for veal. A                    fluralaner.                                             (2) Indications for use. For control of
                                                                                                             (b) Sponsor. See No. 000061 in                     porcine colibacillosis (weanling pig
                                                  withdrawal period has not been
                                                                                                          § 510.600(c) of this chapter.                         scours) caused by susceptible strains of
                                                  established in preruminating calves.
                                                                                                             (c) Conditions of use—(1) Dogs—(i)                 Escherichia coli.
                                                     (2) Swine—(i) Amount. Administer 4                                                                           (3) Limitations. Withdraw 28 days
                                                  mg/lb of body weight by intramuscular                   Amount. Administer topically as a
                                                                                                          single dose every 12 weeks according to               before slaughter.
                                                  injection twice daily for not more than
                                                  3 consecutive days. Continue treatment                  the label dosage schedule to provide a                § 558.68    [Amended]
                                                  24 hours after symptoms disappear. If                   minimum dose of 11.4 mg/lb (25 mg/kg)                 ■ 18. In § 558.68, redesignate
                                                  tylosin medicated drinking water is                     body weight. May be administered every                paragraphs (c) and (d) as paragraphs (d)
                                                  used as a followup treatment for swine                  8 weeks in case of potential exposure to              and (c); and in paragraphs (e)(1)(i) and
                                                  dysentery, the animal should thereafter                 Amblyomma americanum ticks.                           (e)(2)(i), remove ‘‘000986’’ and in its
                                                  receive feed containing 40 to 100 grams                    (ii) Indications for use. Kills adult              place add ‘‘058198’’.
                                                  of tylosin per ton for 2 weeks to assure                fleas; for the treatment and prevention
                                                                                                          of flea infestations (Ctenocephalides                 § 558.128    [Amended]
                                                  depletion of tissue residues.
                                                                                                          felis) and the treatment and control of               ■ 19. In § 558.128, in paragraph
                                                     (ii) Indications for use. Treatment of                                                                     (e)(7)(xi), remove ‘‘§ 558.600’’ and in its
                                                  swine arthritis caused by Mycoplasma                    tick infestations (Ixodes scapularis
                                                                                                          (black-legged tick), Dermacentor                      place add ″§ 558.612″.
                                                  hyosynoviae; swine pneumonia caused
                                                  by Pasteurella spp.; swine erysipelas                   variabilis (American dog tick), and                   § 558.195    [Amended]
                                                  caused by Erysipelothrix rhusiopathiae;                 Rhipicephalus sanguineus (brown dog
                                                                                                          tick)) for 12 weeks in dogs and puppies               ■  20. In § 558.195, in paragraph
                                                  swine dysentery associated with                                                                               (e)(1)(vi), remove ‘‘000009’’ and in its
                                                  Treponema hyodysenteriae when                           6 months of age and older, and weighing
                                                                                                                                                                place add ‘‘054771’’; and in paragraphs
                                                  followed by appropriate medication in                   4.4 lb or greater; for the treatment and
                                                                                                                                                                (e)(2)(iii) and (v), remove ‘‘000986’’
                                                  the drinking water and/or feed.                         control of A. americanum (lone star
                                                                                                                                                                wherever it appears and in its place add
                                                                                                          tick) infestations for 8 weeks in dogs
                                                     (iii) Limitations. Do not inject more                                                                      ‘‘058198’’.
                                                                                                          and puppies 6 months of age and older,
                                                  than 5 mL per site. Adverse reactions,                  and weighing 4.4 lb or greater.                       § 558.261    [Amended]
                                                  including shock and death may result
                                                                                                             (iii) Limitations. Federal law restricts           ■ 21. In § 558.261, redesignate
                                                  from overdosage in baby pigs. It is
                                                                                                          this drug to use by or on the order of                paragraphs (c) and (d) as paragraphs (d)
                                                  recommended that tylosin 50-mg/mL
                                                                                                          a licensed veterinarian.                              and (c).
                                                  injection be used in pigs weighing less
                                                  than 25 lbs. Swine intended for human                      (2) [Reserved]
                                                                                                                                                                § 558.295    [Amended]
                                                  consumption must not be slaughtered                     PART 529—CERTAIN OTHER DOSAGE                         ■ 22. In § 558.295, remove and reserve
                                                  within 14 days of the last use of this                  FORM NEW ANIMAL DRUGS                                 paragraph (b).
                                                  drug product.                                                                                                 ■ 23. In § 558.325, revise paragraph
                                                     (3) Dogs and cats—(i) Amount.                        ■ 13. The authority citation for part 529             (d)(3) to read as follows:
                                                  Administer 3 to 5 mg/lb of body weight                  continues to read as follows:
                                                  by intramuscular injection at 12- to 24-                                                                      § 558.325    Lincomycin.
                                                                                                              Authority: 21 U.S.C. 360b.                        *      *    *     *    *
                                                  hour intervals.
                                                                                                                                                                   (d) * * *
                                                     (ii) Indications for use—(A) Dogs.                   § 529.400    [Amended]
                                                                                                                                                                   (3) Labeling of Type A medicated
                                                  Treatment of upper respiratory                          ■ 14. In § 529.400, in paragraph (a),                 articles and single-ingredient Type B
                                                  infections such as bronchitis,                          remove footnote 1.                                    and Type C medicated feeds containing
                                                  tracheobronchitis, tracheitis, laryngitis,
                                                                                                                                                                lincomycin intended for use in swine
                                                  tonsillitis, and pneumonia caused by                    PART 558—NEW ANIMAL DRUGS FOR                         shall bear the following caution
                                                  Staphylococci spp., hemolytic                           USE IN ANIMAL FEEDS                                   statement: ‘‘The effects of lincomycin on
                                                  Streptococci spp., and Pasteurella
                                                                                                                                                                swine reproductive performance,
                                                  multocida.                                              ■ 15. The authority citation for part 558
                                                                                                                                                                pregnancy, and lactation have not been
                                                     (B) Cats. Treatment of upper                         continues to read as follows:
                                                                                                                                                                determined. Not for use in swine
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                                                  respiratory infections when caused by                     Authority: 21 U.S.C. 354, 360b, 360ccc,             intended for breeding when lincomycin
                                                  Staphylococci spp. and hemolytic                        360ccc–1, 371.                                        is fed at 20 grams per ton of complete
                                                  Streptococci spp. and for feline                                                                              feed.’’
                                                                                                          § 558.58    [Amended]
                                                  pneumonitis when caused by tylosin-
                                                                                                                                                                *      *    *     *    *
                                                  susceptible organisms.                                  ■  16. In § 558.58, in paragraph (e)(6),
                                                     (iii) Limitations. Federal law restricts             remove ‘‘3.6’’ and in its place add                   § 558.342    [Amended]
                                                  this drug to use by or on the order of                  ‘‘36.6’’.                                             ■ 24. In § 558.342, in paragraphs
                                                  a licensed veterinarian.                                ■ 17. Revise § 558.59 to read as follows:             (e)(1)(iv),(ix), (x), and (xi), remove


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                                                                   Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations                                     67153

                                                  ‘‘000986’’ wherever it appears and in its               Electronic Submissions                                information you claim to be confidential
                                                  place add ‘‘058198’’.                                     Submit electronic objections in the                 with a heading or cover note that states
                                                                                                          following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                  § 558.366    [Amended]                                                                                        CONFIDENTIAL INFORMATION.’’ The
                                                                                                            • Federal eRulemaking Portal: http://
                                                  ■  25. In § 558.366, in paragraph (d), in                                                                     Agency will review this copy, including
                                                                                                          www.regulations.gov. Follow the
                                                  the entry for ‘‘113.5 (0.0125 pct)’’,                                                                         the claimed confidential information, in
                                                                                                          instructions for submitting comments.
                                                  remove ‘‘000986’’ and in its place add                                                                        its consideration of comments. The
                                                                                                          Objections submitted electronically,
                                                  ‘‘058198’’.                                                                                                   second copy, which will have the
                                                                                                          including attachments, to http://
                                                  § 558.618    [Amended]                                  www.regulations.gov will be posted to                 claimed confidential information
                                                                                                          the docket unchanged. Because your                    redacted/blacked out, will be available
                                                  ■ 26. In § 558.618, redesignate                                                                               for public viewing and posted on http://
                                                  paragraphs (c) and (d) as paragraphs (d)                objection will be made public, you are
                                                                                                          solely responsible for ensuring that your             www.regulations.gov. Submit both
                                                  and (c).                                                                                                      copies to the Division of Dockets
                                                  ■ 27. In § 558.633, revise paragraph                    objection does not include any
                                                                                                          confidential information that you or a                Management. If you do not wish your
                                                  (d)(1) to read as follows:                                                                                    name and contact information to be
                                                                                                          third party may not wish to be posted,
                                                  § 558.633    Tylvalocin.                                such as medical information, your or                  made publicly available, you can
                                                                                                          anyone else’s Social Security number, or              provide this information on the cover
                                                  *     *     *     *    *
                                                                                                          confidential business information, such               sheet and not in the body of your
                                                    (d) * * *
                                                                                                          as a manufacturing process. Please note               objections and you must identify this
                                                    (1) Federal law restricts medicated
                                                                                                          that if you include your name, contact                information as ‘‘confidential.’’ Any
                                                  feed containing this veterinary feed
                                                                                                          information, or other information that                information marked as ‘‘confidential’’
                                                  directive (VFD) drug to use by or on the
                                                                                                          identifies you in the body of your                    will not be disclosed except in
                                                  order of a licensed veterinarian. See
                                                                                                          objection, that information will be                   accordance with 21 CFR 10.20 and other
                                                  § 558.6 for additional requirements.
                                                                                                          posted on http://www.regulations.gov.                 applicable disclosure law. For more
                                                  *     *     *     *    *                                                                                      information about FDA’s posting of
                                                                                                            • If you want to submit an objection
                                                    Dated: September 21, 2016.                            with confidential information that you                comments to public dockets, see 80 FR
                                                  Tracey Forfa,                                           do not wish to be made available to the               56469, September 18, 2015, or access
                                                  Deputy Director, Center for Veterinary                  public, submit the objection as a                     the information at: http://www.fda.gov/
                                                  Medicine.                                               written/paper submission and in the                   regulatoryinformation/dockets/
                                                  [FR Doc. 2016–23230 Filed 9–29–16; 8:45 am]             manner detailed (see ‘‘Written/Paper                  default.htm.
                                                  BILLING CODE 4164–01–P                                  Submissions’’ and ‘‘Instructions’’).                     Docket: For access to the docket to
                                                                                                                                                                read background documents or the
                                                                                                          Written/Paper Submissions                             electronic and written/paper objections
                                                  DEPARTMENT OF HEALTH AND                                   Submit written/paper submissions as                received, go to http://
                                                  HUMAN SERVICES                                          follows:                                              www.regulations.gov and insert the
                                                                                                             • Mail/Hand delivery/Courier (for                  docket number, found in brackets in the
                                                  Food and Drug Administration                            written/paper submissions): Division of               heading of this document, into the
                                                                                                          Dockets Management (HFA–305), Food                    ‘‘Search’’ box and follow the prompts
                                                  21 CFR Part 573                                         and Drug Administration, 5630 Fishers                 and/or go to the Division of Dockets
                                                                                                          Lane, Rm. 1061, Rockville, MD 20852.                  Management, 5630 Fishers Lane, Rm.
                                                  [Docket No. FDA–2014–F–0988]                               • For written/paper objections                     1061, Rockville, MD 20852.
                                                                                                          submitted to the Division of Dockets                  FOR FURTHER INFORMATION CONTACT:
                                                  Food Additives Permitted in Feed and                    Management, FDA will post your                        Chelsea Trull, Center for Veterinary
                                                  Drinking Water of Animals; Feed Grade                   objection, as well as any attachments,                Medicine, Food and Drug
                                                  Sodium Formate                                          except for information submitted,                     Administration, 7519 Standish Pl.,
                                                                                                          marked and identified, as confidential,               Rockville, MD 20855, 240–402–6729,
                                                  AGENCY:     Food and Drug Administration,
                                                                                                          if submitted as detailed in                           chelsea.trull@fda.hhs.gov.
                                                  HHS.
                                                                                                          ‘‘Instructions.’’                                     SUPPLEMENTARY INFORMATION:
                                                  ACTION:   Final rule.                                      Instructions: All submissions received
                                                                                                          must include the Docket No. FDA–                      I. Background
                                                  SUMMARY:   The Food and Drug
                                                  Administration (FDA, we, the Agency)                    2014–F–0988 for ‘‘Food Additives                         In a document published in the
                                                  is amending the regulations for food                    Permitted in Feed and Drinking Water                  Federal Register of July 25, 2014 (79 FR
                                                  additives permitted in feed and drinking                of Animals; Feed Grade Sodium                         43325), FDA announced that we had
                                                  water of animals to provide for the safe                Formate.’’ Received objections will be                filed a food additive petition (animal
                                                  use of feed grade sodium formate as a                   placed in the docket and, except for                  use) (FAP 2286) submitted by BASF
                                                  feed acidifying agent in complete swine                 those submitted as ‘‘Confidential                     Corp., 100 Park Ave., Florham Park, NJ
                                                  feeds. This action is in response to a                  Submissions,’’ publicly viewable at                   07932. The petition proposed that the
                                                  food additive petition filed by BASF                    http://www.regulations.gov or at the                  regulations for food additives permitted
                                                  Corp.                                                   Division of Dockets Management                        in feed and drinking water of animals be
                                                                                                          between 9 a.m. and 4 p.m., Monday                     amended to provide for the safe use of
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  DATES:  This rule is effective September                through Friday.                                       feed grade sodium formate as a feed
                                                  30, 2016. Submit either electronic or                      • Confidential Submissions—To                      acidifying agent in complete swine
                                                  written objections and requests for a                   submit an objection with confidential                 feeds. The notice of petition provided
                                                  hearing by October 31, 2016. See section                information that you do not wish to be                for a 30-day comment period on the
                                                  V of this document for further                          made publicly available, submit your                  petitioner’s request for categorical
                                                  information on the filing of objections.                objections only as a written/paper                    exclusion from preparing an
                                                  ADDRESSES: You may submit objections                    submission. You should submit two                     environmental assessment or
                                                  and requests for a hearing as follows:                  copies total. One copy will include the               environmental impact statement.


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Document Created: 2018-02-09 13:33:49
Document Modified: 2018-02-09 13:33:49
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; technical amendment.
DatesThis rule is effective September 30, 2016.
ContactGeorge K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]
FR Citation81 FR 67149 
CFR Citation21 CFR 510
21 CFR 520
21 CFR 522
21 CFR 524
21 CFR 529
21 CFR 558
CFR AssociatedAdministrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds

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